Țară: Uniunea Europeană
Limbă: engleză
Sursă: EMA (European Medicines Agency)
sodium oxybate
UCB Pharma Ltd
N07XX04
sodium oxybate
Other nervous system drugs
Cataplexy; Narcolepsy
Treatment of narcolepsy with cataplexy in adult patients.
Revision: 36
Authorised
2005-10-13
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: INFORMATION FOR THE USER XYREM 500 MG/ML ORAL SOLUTION Sodium oxybate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or your pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Xyrem is and what it is used for 2. What you need to know before you take Xyrem 3. How to take Xyrem 4. Possible side effects 5 How to store Xyrem 6. Contents of the pack and other information 1. WHAT XYREM IS AND WHAT IT IS USED FOR Xyrem contains the active substance sodium oxybate. Xyrem works by consolidating night-time sleep, though its exact mechanism of action is unknown. Xyrem is used to treat narcolepsy with cataplexy in adults, adolescents and children from 7 years of age. Narcolepsy is a sleep disorder that may include attacks of sleep during normal waking hours, as well as cataplexy, sleep paralysis, hallucinations and poor sleep. Cataplexy is the onset of sudden muscle weakness or paralysis without losing consciousness, in response to a sudden emotional reaction such as anger, fear, joy, laughter or surprise. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XYREM DO NOT TAKE XYREM - if you are allergic to sodium oxybate or any of the other ingredients of this medicine (listed in section 6); - if you have succinic semialdehyde dehydrogenase deficiency (a rare metabolic disorder); - if you suffer from major depression; - if you are being treated with opioid or barbiturate medicines. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Xyrem: - if you have breathing or lung problems (and especially if you are ob Citiți documentul complet
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Xyrem 500 mg/mL oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution contains 500 mg of sodium oxybate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution. The oral solution is clear to slightly opalescent. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of narcolepsy with cataplexy in adult patients, adolescents and children from the age of 7 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated by and remain under the guidance of a physician experienced in the treatment of narcolepsy. Physicians should strictly adhere to the contraindications, warnings and precautions. Posology Adult The recommended starting dose is 4.5 g/day sodium oxybate divided into two equal doses of 2.25 g/dose. The dose should be titrated to effect based on efficacy and tolerability (see section 4.4) up to a maximum of 9 g/day divided into two equal doses of 4.5 g/dose by adjusting up or down in dose increments of 1.5 g/day (i.e. 0.75 g/dose). A minimum of one to two weeks is recommended between dose increments. The dose of 9 g/day should not be exceeded due to the possible occurrence of severe symptoms at doses of 18 g/day or above (see section 4.4). _ _ Single doses of 4.5 g should not be given unless the patient has been titrated previously to that dose level. If sodium oxybate and valproate are used concomitantly (see section 4.5), a decrease in sodium oxybate dose by 20% is recommended. The recommended starting dose for sodium oxybate, when used concomitantly with valproate, is 3.6 g per day administered orally in two equal divided doses of approximately 1.8 g. If concomitant use is warranted, patient response and tolerability should be monitored and dose should be adapted accordingly (see section 4.4). Discontinuation of Xyrem The discontinuation effects of sodium oxybate have not been systematically evaluated in controlled clinical trials (see sectio Citiți documentul complet